Wound of Skin
Conditions
Brief summary
This is an open, evaluator blinded, intra-comparative, randomized, non-inferiority investigation prior to CE mark to confirm safety and performance of the SWIS device when used as intended, i.e. as an irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds.
Interventions
DEVICESWIS
Bilateral experimental blister wounds on each forearm. The wound on one arm is rinsed with experimental solution (SWIS) and the contralateral wound on the other arm is rinsed With Saline as a comparator.
Sponsors
SoftOx Solutions AS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy and intact skin where the blister suction wounds will be induced * Been informed of the nature, the scope and the relevance of the clinical investigation * Voluntarily agreed to participation and has duly signed the Information Consent Form
Exclusion criteria
1. Participating in any other clinical investigation 2. Disease that may interfere with the wound healing, e.g. diabetes, arterial-, renal-, liver, or cardiac insufficiency, chronic obstructive lung disease, cancer, autoimmune disease, edema of the arm, severe obesity, severe psychiatric disease, dementia or previous known wound healing problems, as judged by the investigator 3. Active skin disease, e.g. dermatitis, psoriasis and wounds, and/or tattoos in the areas where suction blister wounds will be induced, as judged by the investigator 4. Daily smoker 5. Pregnancy 6. Systemic immunosuppressive treatment 7. Uncontrolled pain that may interfere with the investigation outcome, as judged by the investigator 8. Allergy to hypochlorous acid, acetic acid or any other remedies/material used in the clinical investigation 9. Not able to read or understand Danish 10. Any other conditions that as judged by the investigator may make follow-up or investigation inappropriate 11. That according to the Declaration of Helsinki is deemed unsuitable for study enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree (percentage) re-epithelialization in the suction blister wound on day 10 in the SWIS treated wound versus NS treated wound | From baseline to day 10 | Measure the degree of re-epithelialization to evaluate any differences between the treatments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of suction blister wounds healed on day 10 in the SWIS treated wound versus NS treated wound | Day 10 | Evaluate any differences between the two treatments on day 10 |
| Percentage of suction blister wounds healed on day 17 (+/- 1 day) in the SWIS treated wound versus NS treated wound | Day 17 | Evaluate any differences between the two treatments on day 17 |
| Degree (percentage) re-epithelialization in the suction blister wound on day 4 in the SWIS treated wound versus NS treated wound. | From baseline to day 4 | Evaluate any differences between the two treatments on early epithelialization. |
| Subject evaluation of pain during each irrigation procedure on days 0, 2 and 4 in the SWIS treated wound versus NS treated wound | Baseline (day 0), day 2 and day 4 | Evaluate any differences on pain using VAS scale between the SWIS and Normal Saline during irrigation and moistening on day 0,2 and 4. |
| The incidence and severity of adverse events | Baseline to day 17 | Evaluate any differences between the two treatments regarding side effects |
| Percentage of suction blister wounds with >30% CFU reduction in the SWIS treated wound and NS treated wound respectively if positive CFU level prior irrigation | Day 4 | Evaluate any differences between the two treatments on reducing bacterial load in wounds |
Countries
Denmark
Outcome results
None listed